A Phase III, Clinical Trial to Evaluate the safety, tolerability and efficacy of 2 Fixed dose combinations of Azelnidipine and Olmesartan when compared with fixed dose combination of Amlodipine and Olmesartan in patients with Stage II hypertension.

â??A Phase III Randomized, Double Blind, Parallel Group Comparative Clinical Trial to Evaluate the safety, tolerability and efficacy of Fixed dose combinations of Azelnidipine 8 mg + Olmesartan 20 mg and Azelnidipine 8 mg + Olmesartan 40 mg when compared with fixed dose combination of Amlodipine 5 mg + Olmesartan 20 mg in patients with Stage II hypertension.â??

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/023062

Enrollment

210

Registered

2020-01-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I159- Secondary hypertension, unspecified

Interventions

Intervention1: Azelnidipine 8 mg and Olmesartan 20 mg: Azelnidipine 8 mg and Olmesartan 20 mg 1 tablet to be taken daily, orally with plain water after meal daily for 84 days. Intervention2: Azelnidip

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of either sex aged between 18 to 75 years 2.Signed written informed consent obtained prior to inclusion in the study. 3.Patient diagnosed with Stage II hypertension (SBP >=160 to =100 to 4.Subjects willing to adhere to protocol and study requirements during the entire study duration 5.Subjects having no abnormalities in general physical examination

Exclusion criteria

Exclusion criteria: 1. Not willing to sign the ICF 2.Known or suspected secondary hypertension. 3.Mean SBP equal to or greater than 200 mmHg 4.Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor 5.Patients with significant hepatic disease (liver function tests x 2 upper limit of normal reference range) or significant renal disease (creatinine x 2 upper limit of normal reference range) 6.Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney 7.Uncorrected volume or sodium depletion or hyponatremia

Design outcomes

Primary

Measure	Time frame
The Primary objective of this trial is to find out safety and tolerability of the product.Timepoint: Visit 1 to Visit 5	—

Secondary

Measure	Time frame
Difference in mean change in DBP from baseline at the end of 12 weeks between each FDC groupTimepoint: Visit 1 to Visit 5;Difference in mean change in SBP from baseline at the end of 12 weeks between each FDC group Timepoint: Visit 1 to Visit 5	—

Countries

India

Contacts

Public ContactDr Devesh Kumar

IR Innovate Research Private Limited

devesh.kumar@innovate-research.com9971169602

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026